Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease

Intervertebral Disc Degeneration Clinical Trial

— TLIF  

Official title:

Safety and Performance of the Hexanium TLIF System in the Treatment of Skeletally Mature Patients Suffering From Degenerative Disc Disease - Hexanium TLIF Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05997121
• Other study ID #: SV005
• Status: Recruiting
• Start date: July 9, 2021
• Est. completion date: October 30, 2027

Study information

• Verified date: August 2023
• Source: SpineVision
• Contact: Renaud Duchenes
• Phone: +33 6 86 16 61 91
• Email: r.duchenes[@]spinevision.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to confirm the safety and efficacy of the Hexanium TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk break down).

Part of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Hexanium TLIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium TLIF system implant surgery.

Description:

The Hexanium TLIF study is a multicentric, international, ambispective, post market clinical follow-up study. This means that either subjects already implanted with the Hexanium TLIF system (retrospective subjects) or subjects planned for treatment with the Hexanium TLIF (prospective subjects) can be enrolled in the study.

Standard of care subjects data up to twenty four (24) months post Hexanium TLIF system implant procedure will be collected; key data include back and leg Visual Analogue Score (VAS), Oswestry Disability Index (ODI) score, and adverse events.

Data will be collected at Month 2, Month 6, Month 12 and Month 24 post surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 187
• Est. completion date: October 30, 2027
• Est. primary completion date: October 30, 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient planned for Hexanium TLIF system implant or patient implant with Hexanium TLIF system (not prior to July 2021)

• Patient of 18 years old or more

• Patient has provided signed informed consent, or did not oppose to his/her data collection, per local regulation

Exclusion Criteria: contra-indication

• Infection, local to the operative site

• Signed of local inflammation

• Fever or leukocytosis

• Morbid obesity

• Pregnancy

• Paediatric cases, or patient still having general skeletal growth

• Spondylolisthesis unable to be reduced to Grade I

• Suspected or documented allergy or intolerance to metal

• Any case where the implant components selected for use would be too large or too small to achieve a successful result

• Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality

• Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance

• Prior fusion at the level to be treated

• Any case not needing a bone graft or fusion

• Any abnormality present which affects the normal process of bone remodelling including, but not limited to severe osteoporosis involving spine, bone absorption, osteopenia, primary or metastasis tumours involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis

• Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumours or congenital abnormalities, fracture local to operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count

• Mental illness

• Any patient unwilling to cooperate with post-operative instructions

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration

Intervention

Device:
• Transforaminal lumbar interbody fusion
Transforaminal Lumbar Interbody Fusion indicates a surgical approach in the lumbar spine to fuse the discal space between two vertebrae. These are joined by removing the disc and placing a cage in its place to restore the vertebral height. Screws and rods are also added to maintain the level secure while the bones fuse together.

Locations

Country	Name	City	State
France	Clinique du dos Terrefort	Bruges
France	Clinique Saint Charles	Lyon
France	Hopital privé Clairval	Marseille
France	CHRU Nancy	Nancy
France	Polyclinique Majorelle	Nancy
Switzerland	Clinicque Générale Beaulieu	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
SpineVision	EVAMED

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious adverse device and/or procedure related events	Rate of the serious adverse events related to the study device and / or surgical implant procedure will be analyzed and compared to the state of the art.	Month 24
Primary	Change of the Oswestry Disability Index (ODI)	ODI mean score at Month 12 will be compared to the ODI mean score at baseline.	Month 12
Secondary	Fusion success	Fusion rate will be analyzed and compared to the state of the art.	Month 2, month 6, month 12 and month 24
Secondary	Change of the Oswestry Disability Index (ODI)	Mean ODI score evolution score will be analyzed.	Month 2, month 6, and month 24
Secondary	Change of the back and leg Visual Analogue Score (VAS)	Back and leg VAS assessment will be analyzed.	Month 2, month 6, month 12 and month 24
Secondary	Incidence of revision surgery at implant site	Rate of revision surgery at implant site will be analyzed and compared to the state of the art.	Month 2, month 6, month 12 and month 24